Desoximetasone 0.25% Crm 15gm

Manufacturer TARO Active Ingredient Desoximetasone Cream, Gel, and Ointment(des oks i MET a sone) Pronunciation des oks i MET a sone
It is used to treat skin irritation.It is used to treat skin rashes.
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Drug Class
Topical Corticosteroid
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Pharmacologic Class
Synthetic Adrenocorticosteroid
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Pregnancy Category
Category C
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FDA Approved
Aug 1977
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Desoximetasone is a strong corticosteroid medicine applied to the skin to reduce inflammation, redness, and itching caused by various skin conditions like eczema or psoriasis. It works by calming down the body's immune response in the skin.
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How to Use This Medicine

Using Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions precisely. Continue using the medication as directed, even if your symptoms improve.

Applying the Medication

This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. Do not take it by mouth. Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. Do not apply it to the vagina.

Before applying the medication, wash your hands thoroughly. If the affected area is on your hand, you do not need to wash that hand after application. Clean the affected area before applying the medication and make sure it is completely dry. Apply a thin layer of the medication to the affected skin and gently rub it in.

Unless instructed to do so by your doctor, do not cover the treated area with bandages or dressings.

Storing and Disposing of Your Medication

Store the medication at room temperature, away from heat and moisture. Keep all medications in a safe place, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless you are instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are any drug take-back programs in your area.

Missing a Dose

If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and continue with your regular schedule. Do not apply two doses at the same time or extra doses to make up for a missed one.
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Lifestyle & Tips

  • Wash hands before and after applying the cream.
  • Apply a thin layer to the affected skin area only, as directed by your doctor. Do not use more than prescribed.
  • Do not apply to the face, groin, or armpits unless specifically instructed by your doctor.
  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • Do not bandage, wrap, or cover the treated skin area unless your doctor tells you to, as this can increase absorption and side effects.
  • Do not use for longer than prescribed, especially on children, as prolonged use can lead to skin thinning or other side effects.
  • Inform your doctor if your condition worsens or does not improve after 2 weeks of treatment.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin film to the affected skin areas twice daily.

Condition-Specific Dosing:

psoriasis: Apply a thin film to the affected skin areas twice daily.
atopicDermatitis: Apply a thin film to the affected skin areas twice daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Use with caution; not recommended for prolonged use or on large body surface areas due to increased risk of systemic absorption and adrenal suppression. Generally, for children 10 years and older, apply a thin film to the affected skin areas twice daily, for short durations.
Adolescent: Apply a thin film to the affected skin areas twice daily.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No specific considerations due to minimal systemic absorption.

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed

Pharmacology

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Mechanism of Action

Desoximetasone is a synthetic corticosteroid. Topical corticosteroids, such as desoximetasone, are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. Corticosteroids also possess vasoconstrictive and antiproliferative actions.
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Pharmacokinetics

Absorption:

Bioavailability: Varies (minimal systemic absorption)
Tmax: Not precisely defined for topical application due to variable absorption
FoodEffect: Not applicable for topical administration

Distribution:

Vd: Not precisely defined for topical application
ProteinBinding: Systemically absorbed corticosteroids are bound to plasma proteins in varying degrees (e.g., transcortin, albumin).
CnssPenetration: Limited (minimal systemic absorption)

Elimination:

HalfLife: Not precisely defined for topical application
Clearance: Not precisely defined for topical application
ExcretionRoute: Metabolites are primarily excreted by the kidneys, with some biliary excretion.
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Hours to days (for anti-inflammatory effect)
PeakEffect: Days to weeks (for maximal therapeutic effect)
DurationOfAction: Varies depending on application frequency and condition

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Attention Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Feeling extremely tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Thinning of the skin
Changes in eyesight

Other Possible Side Effects

Like all medications, this drug may cause side effects in some people. Many individuals experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help if they bother you or do not go away:

Burning, itching, dryness, or other irritation at the site where the medication was applied

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Worsening of the skin condition or no improvement after 2 weeks
  • Signs of skin infection (e.g., increased redness, swelling, pus, fever)
  • Severe burning, itching, or irritation at the application site
  • Skin thinning, easy bruising, or stretch marks (striae) in the treated area
  • Changes in skin color (lightening or darkening)
  • Unusual hair growth in the treated area
  • Acne-like breakouts
  • Signs of systemic absorption, especially in children or with extensive use: weight gain, 'moon face', fatigue, muscle weakness, increased thirst or urination.
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist identify potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

When applying this medication to the diaper area, avoid using tight-fitting diapers or plastic pants, as this can increase the amount of medication absorbed into the body.

Before using any other medications or products on your skin, including soaps, consult with your doctor to ensure safe use.

Do not apply this medication to cuts, scrapes, or damaged skin. Exercise caution when applying it to large areas of skin or near open wounds, and discuss any concerns with your doctor.

Use this medication only for the duration prescribed by your doctor. Do not exceed the recommended treatment period.

Be aware that this medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor.

In children and teenagers, this medication may affect growth in some cases. Regular growth checks may be necessary, so consult with your doctor to monitor growth and development.

When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this age group.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.

If you are breastfeeding, avoid applying this medication to your chest. Instead, consult with your doctor for guidance on safe use.
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Overdose Information

Overdose Symptoms:

  • Prolonged or excessive use can lead to systemic absorption, potentially causing symptoms of hypercorticism (Cushing's syndrome), hyperglycemia, and adrenal suppression. Symptoms may include: weight gain, 'moon face', central obesity, thinning skin, easy bruising, muscle weakness, fatigue, high blood pressure, increased blood sugar, and growth retardation in children.

What to Do:

Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment should be initiated. Call a poison control center (1-800-222-1222) or seek immediate medical attention if severe symptoms occur.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatosis and identify any pre-existing skin integrity issues.

Timing: Prior to initiation of therapy

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Routine Monitoring

Local skin reactions (e.g., atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, miliaria)

Frequency: Regularly during therapy, especially with prolonged use

Target: Absence or minimal severity of reactions

Action Threshold: If severe or persistent, discontinue use and reassess treatment.

Signs of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, glucosuria, adrenal suppression)

Frequency: Periodically, especially with extensive, prolonged, or occlusive use, or in pediatric patients.

Target: Normal adrenal function, blood glucose levels

Action Threshold: If suspected, perform appropriate tests (e.g., ACTH stimulation test, plasma cortisol, urinary free cortisol, blood glucose). Discontinue or reduce frequency if abnormalities detected.

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Symptom Monitoring

  • Worsening of skin condition
  • Increased redness, swelling, or pus (signs of infection)
  • Severe burning, itching, or stinging at application site
  • Skin thinning, easy bruising, or stretch marks (striae)
  • Increased hair growth in treated areas
  • Acne-like breakouts
  • Changes in skin color (lightening or darkening)
  • Fatigue, weight gain, 'moon face', muscle weakness, increased thirst/urination (signs of systemic absorption)

Special Patient Groups

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Pregnancy

Category C. There are no adequate and well-controlled studies in pregnant women. Desoximetasone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity observed in animal studies with high systemic doses of corticosteroids. Risk in humans is uncertain with topical use.
Second Trimester: Risk of fetal growth retardation or adrenal suppression with prolonged or extensive use of potent corticosteroids.
Third Trimester: Risk of fetal growth retardation or adrenal suppression with prolonged or extensive use of potent corticosteroids. Neonates born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
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Lactation

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Caution should be exercised when desoximetasone is administered to a nursing woman. If used, apply to the smallest area possible and avoid application to the breast area to prevent infant ingestion.

Infant Risk: Low risk with appropriate use due to minimal systemic absorption, but theoretical risk of growth suppression or other adverse effects if significant amounts are absorbed by the infant.
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Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Prolonged use of topical corticosteroids in children should be avoided. Not recommended for children under 10 years for prolonged use. If used, apply sparingly and for short durations.

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Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may have thinner skin, which could potentially increase systemic absorption, though this is generally not clinically significant with appropriate use.

Clinical Information

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Clinical Pearls

  • Desoximetasone 0.25% cream is a high-potency topical corticosteroid. Use it judiciously and for the shortest duration necessary to achieve control of symptoms.
  • Avoid prolonged use (typically more than 2-4 weeks) to minimize the risk of local side effects like skin atrophy, striae, and telangiectasias.
  • Not generally recommended for use on the face, groin, or axillae due to increased risk of local side effects and systemic absorption in these sensitive areas, unless specifically directed by a dermatologist.
  • Occlusive dressings significantly increase systemic absorption and should only be used under strict medical supervision.
  • Educate patients on proper application technique: apply a thin film, rub in gently, and wash hands after use.
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Alternative Therapies

  • Other high-potency topical corticosteroids (e.g., Clobetasol propionate, Halobetasol propionate, Fluocinonide)
  • Medium-potency topical corticosteroids (e.g., Triamcinolone acetonide, Mometasone furoate)
  • Low-potency topical corticosteroids (e.g., Hydrocortisone)
  • Topical calcineurin inhibitors (e.g., Tacrolimus, Pimecrolimus) for steroid-sparing therapy, especially on sensitive areas.
  • Emollients and moisturizers for barrier repair and symptom relief.
  • Systemic therapies (e.g., oral corticosteroids, biologics) for severe, widespread, or recalcitrant dermatoses.
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Cost & Coverage

Average Cost: Varies widely by pharmacy and formulation (e.g., $30-$150+) per 15gm tube
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (for generic), Tier 3 or Tier 4 (for brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.